NCT01512160终止2 期
A Randomized, Double-Blind Third Party Open, Double-Dummy, Parallel Group, Placebo Controlled Study Assessing The Efficacy Of Single Doses Of Pf-04531083 For The Treatment Of Post-Surgical Dental Pain Using Ibuprofen 400 Mg As A Positive Control
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Total Pain Relief (TOTPAR) Score From 0 to 6 Hours
研究概览
简要总结
The purpose of this study is to evaluate the overall pain relief of a single dose of PF-04531083 against placebo following third molar extraction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Oral surgical procedure having removed 2 third molars (unilateral).
- •Pre-dose pain intensity score (100 mm Visual Analog Scale [VAS]) >50 mm within 5 hours of oral surgery.
- •Pre-dose pain intensity score of moderate or within 5 hours of oral surgery.
排除标准
- •Presence or history of any significant hepatic, renal, endocrine, cardiovascular, neurological (including subjects with a history of frequent moderate to severe headaches or subjects with episodic migraines more than twice per month), psychiatric, gastrointestinal, pulmonary, hematologic, or metabolic disorder.
- •Prior use of any type of analgesic or NSAID within five half-lives of that drug or less before taking the first dose of study medication, except for anesthesia for the procedure.
- •Recent history of chronic analgesic or tranquilizer dependency.
- •Active dental infection at the time of surgery.
- •Any significant oral surgery complication at the time of surgery or in the immediate postoperative period or dental surgery lasting > 30 minutes.
- •Subjects who are smokers.
研究组 & 干预措施
PF-04531083 2000 mg
Experimental
干预措施: PF-04531083 (Drug)
PF-04531083 2000 mg
Experimental
干预措施: Placebo (Other)
PF-04531083 1000 mg
Experimental
干预措施: PF-04531083 (Drug)
PF-04531083 1000 mg
Experimental
干预措施: Placebo (Other)
Ibuprofen 400 mg
Active Comparator
干预措施: Ibuprofen (Drug)
Ibuprofen 400 mg
Active Comparator
干预措施: Placebo (Other)
Placebo
Placebo Comparator
干预措施: Placebo (Other)
结局指标
主要结局
Total Pain Relief (TOTPAR) Score From 0 to 6 Hours
时间窗: 0 to 6 hours
TOTPAR \[6\] was defined as the area under the pain relief (PR) curve through the first 6 hours after dosing. Area under the curve (AUC) was calculated using the trapezoid rule with PR was assumed to be 0 at time=0. PR assessed on a 5-point categorical scale; 0 (none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete), at 15, 30, 45, minutes and at different time points during the study up to 6 hours post-dose. Total score range for TOTPAR \[6\]: 0 (worst) - 24 (best), higher value of TOTPAR indicated greater degree of PR.
次要结局
- Supine Pulse Rate(Screening, Day 0, 1 (pre-dose), 2, 10-14 (Follow-up))
- Number of Participants With Peak Pain Relief (PPR)(0 to 24 hours)
- Time-specific Pain Relief (PR) Score(0, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 6, 8, 24 hours, prior to rescue medication (RM))
- Time-specific Pain Intensity Difference (PID) Score(15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 6, 8, 24 hours, prior to RM)
- Summed Pain Intensity Difference (SPID) Score at 6 Hours and 24 Hours(0 to 6, 0 to 24 hours)
- Total Pain Relief (TOTPAR) Score From 0 to 24 Hours(0 to 24 hours)
- Time to Onset of First Perceptible Pain Relief (PR)(0 to 24 hours)
- Time to Onset of First Meaningful Pain Relief (PR)(0 to 24 hours)
- Time to First Use of Rescue Medication(1.5 to 24 hours)
- Number of Participants With Rescue Medication(0 to 24 hours)
- Participant Global Evaluation of Study Medication(6, 24 hours, prior to RM)
- Participant Satisfaction Questionnaire(6, 24 hours, prior to RM)
- Maximum Observed Plasma Concentration (Cmax) of PF-04531083(0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose)
- Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04531083(0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose)
- Area Under the Curve From Time Zero to 6 Hour [AUC (0-6)] of PF-04531083(0 (pre-dose), 1, 2, 4, 6 hours post-dose)
- Area Under the Curve From Time Zero to 24 Hour [AUC (0-24)] of PF-04531083(0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose)
- Maximum Observed Plasma Concentration (Cmax) of Ibuprofen(0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose)
- Time to Reach Maximum Observed Plasma Concentration (Tmax) of Ibuprofen(0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose)
- Area Under the Curve From Time Zero to 6 Hour [AUC (0-6)] of Ibuprofen(0 (pre-dose), 1, 2, 4, 6 hours post-dose)
- Area Under the Curve From Time Zero to 24 Hour [AUC (0-24)] of Ibuprofen(0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose)
- Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)(Baseline up to Day 10-14 (Follow-up))
- Number of Participants With Clinically Significant Laboratory Test Abnormality(Baseline up to Day 10-14 (Follow-up))
- Supine Systolic and Diastolic Blood Pressure (BP)(Screening, Day 0, 1 (pre-dose), 2, 10-14 (Follow-up))
- 12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)(Screening, Day 1, 2, 10-14 (Follow-up))
- 12-Lead Electrocardiogram (ECG) Parameter (Heart Rate)(Screening, Day 1, 2, 10-14 (Follow-up))
研究者
研究点 (1)
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